Acute Hypercapnic Respiratory FailureUNDER PRESSURENCT04102735
Under the Nose Face Mask to Prevent Facial Pressure Ulcers During NIV for Acute Hypercapnic Respiratory Failure (AHRF)
A study testing Under-the-nose facemask and Over-the-nose facemask in people with Acute Hypercapnic Respiratory Failure, run by Centre Hospitalier Arras at 2 sites in France.
Trial summary
Noninvasive ventilation (NIV) is essential to treat acute hypercapnic respiratory failure. However, facial pressure ulcers appearing during facemask-delivered noninvasive ventilation are a source of NIV failure by interface intolerance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypercapnic Respiratory Failure
- What is being tested?
- Under-the-nose facemask and Over-the-nose facemask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Nov 2018to 3 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute hypercapnic respiratory failure
- Initiation of NIV
- Estimated cumulative time of NIV upper than 12 hours for the first 48 hours of hospitalization
Who cannot join
- Contraindication for NIV (respiratory arrest, impossibility to fit the mask)
- Intubated patient
- Patient with a tracheostomy
- Post-extubation respiratory failure
- Patient exhibiting facial ulcers or skin lesions located at the insertion points of the mask before its hospitalization
- Person declining NIV
- Pregnancy
- Dying person
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: UNDER the Nose vs. Over the Nose Face Mask to Prevent Facial PRESSURE Ulcers During Face Mask-noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
Noninvasive ventilation (NIV) is essential to treat acute hypercapnic respiratory failure. However, facial pressure ulcers appearing during facemask-delivered noninvasive ventilation are a source of NIV failure by interface intolerance.
A Philips facemask (model : AF541 SE Oro-Nasal mask) has the particularity to display two options for its positioning : a usually used "over-the-nose" positioning or an "under-the-nose" positioning that is supposed to reduce the incidence of facial pressure ulcers while keeping in the same time the qualities of a standard facemask.
Read more
The goal of this controlled randomized trial is to test the hypothesis that the "under-the-nose" positioning actually reduces the incidence of facial pressure ulcers, compared to the usually used "over-the-nose" positioning.
Results of this trial should lead to the proposition of a new interface strategy to prevent facial pressure ulcers and therefore to improve the tolerance of NIV via the use of facemasks displaying an "under-the-nose" positioning.
- Conditions
- Acute Hypercapnic Respiratory Failure
- Being tested
- Under-the-nose facemask, Over-the-nose facemask
- Keywords
- facial pressure ulcers, noninvasive ventilation, acute hypercapnic respiratory failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Under-the-nose facemaskDevice
Patients with acute hypercapnic respiratory failure that need noninvasive ventilation and are randomized in the experimental group will receive the AF541 facemask used with the under-the-nose cushion.
Over-the-nose facemaskDevice
Patients with acute hypercapnic respiratory failure that need non-invasive ventilation and are randomized in the comparator group will receive the AF541 facemask used with the over-the-nose cushion.
| Study group | Role | What they receive |
|---|---|---|
| Over-the-nose facemask | Active comparator | The AF541 oro-nasal mask is used with the over-the-nose mask cushion. Receives: Device: Over-the-nose facemask |
| Under-the-nose facemask | Experimental | The AF541 oro-nasal mask is used with the under-the-nose mask cushion. Receives: Device: Under-the-nose facemask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the incidence of facial pressure ulcers in the experimental arm compared to the control arm, within the first 3 days after NIV initiation.
The primary endpoint is the development of a facial pressure ulcer within the first 3 days after NIV initiation
Measured: 3 days after NIV initiation
Secondary outcomes (5)
Change of the delay for facial pressure ulcers to appear in the experimental arm, compared to the control arm
This secondary endpoint is the delay (in hours) between NIV initiation and the development of a facial pressure ulcer.
Measured: 7 days after NIV initiation
Change of the severity of facial pressure ulcers in the experimental arm, compared to the control arm
This secondary endpoint is the highest facial pressure ulcer severity score observed during patient hospitalization. This score is evaluated according to the National Pressure Ulcer Advisory Panel guidelines (Edsberg LE et al., 2016). Stage 1 pressure injury (the less severe score) corresponds to intact skin with a localized area of nonblanchable erythema. Stage 2 pressure injury corresponds to partial-thickness skin loss with exposed dermis. Stage 3 pressure injury corresponds to full-thickness skin loss. Stage 4 pressure injury (the most severe score) corresponds to full-thickness skin and tissue loss.
Measured: 7 days after NIV initiation
Change of the patient comfort in the experimental arm, compared to the control arm
This secondary endpoint is the comfort patient score at 24 hours after NIV initiation. This score is a numeric scale, validated for NIV (Lemyze M et al., 2013 ; Gregoretti C et al., 2002), going from 1 to 5 (1: very uncomfortable ; 2: uncomfortable ; 3: acceptable ; 4: quite comfortable ; 5: comfortable).
Measured: 24 hours after NIV initiation
Change of the incidence of mask changes related to interface intolerance in the experimental arm, compared to the control arm
This secondary endpoint is the incidence of mask changes related to interface intolerance during patient hospitalization.
Measured: 7 days after NIV initiation
Change of the incidence of NIV failure in the experimental arm, compared to the control arm
This secondary endpoint is the incidence of NIV failure defined as the need to resort to intubation or palliative care (in the case of a do-not-intubate order) during patient hospitalization. NIV failures may be caused by refractory respiratory acidosis, refractory hypoxemia, pressure ulcers, interface intolerance, excessive unintentional air leaks or shock.
Measured: 7 days after NIV initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start21 Nov 2018
- Primary completion3 Oct 2021
- Study completion3 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Arras
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm LEMYZE, MD, Principal investigator, Centre Hospitalier Arras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102735
- Sponsor's protocol ID
- 2017-02
- Acronym
- UNDER PRESSURE
- Status last verified
- Mar 2022
- First submitted
- 17 May 2019
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Edsberg LE, Black JM, Goldberg M, McNichol L, Moore L, Sieggreen M. Revised National Pressure Ulcer Advisory Panel Pressure Injury Staging System: Revised Pressure Injury Staging System. J Wound Ostomy Continence Nurs. 2016 Nov/Dec;43(6):585-597. doi: 10.1097/WON.0000000000000281.
PubMed 27749790Lemyze M, Mallat J, Nigeon O, Barrailler S, Pepy F, Gasan G, Vangrunderbeeck N, Grosset P, Tronchon L, Thevenin D. Rescue therapy by switching to total face mask after failure of face mask-delivered noninvasive ventilation in do-not-intubate patients in acute respiratory failure. Crit Care Med. 2013 Feb;41(2):481-8. doi: 10.1097/CCM.0b013e31826ab4af.
PubMed 23263582Gregoretti C, Confalonieri M, Navalesi P, Squadrone V, Frigerio P, Beltrame F, Carbone G, Conti G, Gamna F, Nava S, Calderini E, Skrobik Y, Antonelli M. Evaluation of patient skin breakdown and comfort with a new face mask for non-invasive ventilation: a multi-center study. Intensive Care Med. 2002 Mar;28(3):278-84. doi: 10.1007/s00134-002-1208-7. Epub 2002 Feb 6.
PubMed 11904656Lemyze M, Mallat J, Vangrunderbeek N, Granier M. Under-The-Nose Versus Over-The-Nose Face Mask to Prevent Facial Pressure Sores During Face Mask-Delivered Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure: A Randomized Controlled Trial. Crit Care Med. 2023 Sep 1;51(9):1177-1184. doi: 10.1097/CCM.0000000000005902. Epub 2023 May 11.
PubMed 37166242
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UNDER the Nose vs. Over the Nose Face Mask to Prevent Facial PRESSURE Ulcers During Face Mask-noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT04102735
- Acronym / sponsor ID
- UNDER PRESSURE / 2017-02
- Conditions
- Acute Hypercapnic Respiratory Failure
- Keywords
- facial pressure ulcers, noninvasive ventilation, acute hypercapnic respiratory failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Centre Hospitalier ArrasUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 3 Oct 2021 (actual)
- Study completion
- 3 Oct 2021 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Noninvasive ventilation (NIV) is essential to treat acute hypercapnic respiratory failure. However, facial pressure ulcers appearing during facemask-delivered noninvasive ventilation are a source of NIV failure by interface intolerance.
A Philips facemask (model : AF541 SE Oro-Nasal mask) has the particularity to display two options for its positioning : a usually used "over-the-nose" positioning or an "under-the-nose" positioning that is supposed to reduce the incidence of facial pressure ulcers while keeping in the same time the qualities of a standard facemask.
The goal of this controlled randomized trial is to test the hypothesis that the "under-the-nose" positioning actually reduces the incidence of facial pressure ulcers, compared to the usually used "over-the-nose" positioning.
Results of this trial should lead to the proposition of a new interface strategy to prevent facial pressure ulcers and therefore to improve the tolerance of NIV via the use of facemasks displaying an "under-the-nose" positioning.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Over-the-nose facemask | Active comparator | Device: Over-the-nose facemaskThe AF541 oro-nasal mask is used with the over-the-nose mask cushion. |
| Under-the-nose facemask | Experimental | Device: Under-the-nose facemaskThe AF541 oro-nasal mask is used with the under-the-nose mask cushion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute hypercapnic respiratory failure
- Initiation of NIV
- Estimated cumulative time of NIV upper than 12 hours for the first 48 hours of hospitalization
Key exclusion criteria (8 listed)
- Contraindication for NIV (respiratory arrest, impossibility to fit the mask)
- Intubated patient
- Patient with a tracheostomy
- Post-extubation respiratory failure
- Patient exhibiting facial ulcers or skin lesions located at the insertion points of the mask before its hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Under-the-nose facemaskPatients with acute hypercapnic respiratory failure that need noninvasive ventilation and are randomized in the experimental group will receive the AF541 facemask used with the under-the-nose cushion. | Device | Under-the-nose facemask |
| Over-the-nose facemaskPatients with acute hypercapnic respiratory failure that need non-invasive ventilation and are randomized in the comparator group will receive the AF541 facemask used with the over-the-nose cushion. | Device | Over-the-nose facemask |
Primary outcome
Change of the incidence of facial pressure ulcers in the experimental arm compared to the control arm, within the first 3 days after NIV initiation.
Time frame: 3 days after NIV initiation
The primary endpoint is the development of a facial pressure ulcer within the first 3 days after NIV initiation
5 secondary outcomes
Change of the delay for facial pressure ulcers to appear in the experimental arm, compared to the control arm
Time frame: 7 days after NIV initiation
Change of the severity of facial pressure ulcers in the experimental arm, compared to the control arm
Time frame: 7 days after NIV initiation
Change of the patient comfort in the experimental arm, compared to the control arm
Time frame: 24 hours after NIV initiation
Change of the incidence of mask changes related to interface intolerance in the experimental arm, compared to the control arm
Time frame: 7 days after NIV initiation
Change of the incidence of NIV failure in the experimental arm, compared to the control arm
Time frame: 7 days after NIV initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Background: PubMed 27749790Edsberg LE, Black JM, Goldberg M, McNichol L, Moore L, Sieggreen M. Revised National Pressure Ulcer Advisory Panel Pressure Injury Staging System: Revised Pressure Injury Staging System. J Wound Ostomy Continence Nurs. 2016 Nov/Dec;43(6):585-597. doi: 10.1097/WON.0000000000000281.
- Background: PubMed 23263582Lemyze M, Mallat J, Nigeon O, Barrailler S, Pepy F, Gasan G, Vangrunderbeeck N, Grosset P, Tronchon L, Thevenin D. Rescue therapy by switching to total face mask after failure of face mask-delivered noninvasive ventilation in do-not-intubate patients in acute respiratory failure. Crit Care Med. 2013 Feb;41(2):481-8. doi: 10.1097/CCM.0b013e31826ab4af.
- Background: PubMed 11904656Gregoretti C, Confalonieri M, Navalesi P, Squadrone V, Frigerio P, Beltrame F, Carbone G, Conti G, Gamna F, Nava S, Calderini E, Skrobik Y, Antonelli M. Evaluation of patient skin breakdown and comfort with a new face mask for non-invasive ventilation: a multi-center study. Intensive Care Med. 2002 Mar;28(3):278-84. doi: 10.1007/s00134-002-1208-7. Epub 2002 Feb 6.
- Derived from this study: PubMed 37166242Lemyze M, Mallat J, Vangrunderbeek N, Granier M. Under-The-Nose Versus Over-The-Nose Face Mask to Prevent Facial Pressure Sores During Face Mask-Delivered Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure: A Randomized Controlled Trial. Crit Care Med. 2023 Sep 1;51(9):1177-1184. doi: 10.1097/CCM.0000000000005902. Epub 2023 May 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm LEMYZE, MD principal investigator
Centre Hospitalier Arras
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Under-the-nose facemask and Over-the-nose facemask in people with Acute Hypercapnic Respiratory Failure, run by Centre Hospitalier Arras at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the incidence of facial pressure ulcers in the experimental arm compared to the control arm, within the first 3 days after NIV initiation. (time frame: 3 days after NIV initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04102735, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.